RapidAI announced that it received FDA 510(k) clearance for its Lumina 3D automated 3D imaging reconstruction solution.

Inspira Technologies integrates an AI-powered oxygenation indicator into its HYLA sensor, aiming to enhance real-time ...

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

More than 10 million babies have been born through IVF, yet the process is still invasive and costly. Plus, why a venture ...

Results from the study assisted Notal Vision in receiving De Novo authorization from the US FDA for the SCANLY Home OCT in ...

We recently published a list of 10 AI News and Ratings Too Important to Miss. In this article, we are going to take a look at where GE HealthCare Technologies Inc.

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading key policies on artificial intelligence and software as a medical device.

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

with a focus on AI collaboration. On January 28, it was announced that GE HealthCare (NASDAQ:GEHC) received FDA 510(k) clearance for its updated Voluson Expert Series ultrasound systems ...